| 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01672 | 說明 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | 每股發行/出售價 (註4) | 已發行股份總數 | | 於下列日期開始時的結存(註1) | 2025年10月15日 | 992,874,320 | | 6,084,210 | | 998,958,530 | | 1). 購回股份 (股份被持作庫存股份) | | | -100,000 0.0101 % | 100,000 HKD | 9.1525 | | | 變動日期 | 2025年10月17日 | | | | | | | 於下 ...

Core Viewpoint - The company, Gilead Sciences-B (01672), announced a share buyback plan, indicating confidence in its financial position and future prospects [1] Group 1 - The company will repurchase 100,000 shares at a total cost of HKD 948,700 [1] - The buyback price per share ranges from HKD 9.31 to HKD 9.60 [1] - The repurchase is scheduled for October 15, 2025 [1]

Core Viewpoint - The company, Gilead Sciences-B (01672), announced a share buyback plan, indicating confidence in its stock value and future prospects [1] Group 1 - The company will repurchase 100,000 shares at a total cost of HKD 948,700 [1] - The buyback price per share ranges from HKD 9.31 to HKD 9.60 [1] - The buyback is scheduled to take place on October 15, 2025 [1]

Core Viewpoint - The company, Gilead Sciences-B (01672.HK), announced a share buyback of 100,000 shares at a cost of HKD 949,000 on October 15 [1] Group 1 - The total expenditure for the share buyback was HKD 949,000 [1] - The number of shares repurchased was 100,000 [1]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 歌禮製藥有限公司 呈交日期： 2025年10月15日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01672 | 說明 | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | 事件 | | 已發行股份（不包括庫存股份）數 目 | ...

Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a stock increase of over 4% following the announcement of its new drug application progress for ASC40, aimed at treating moderate to severe acne, and the selection of ASC35 as a clinical development candidate for obesity treatment [1] Group 1: Drug Development Updates - Gilead has completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding ASC40 for treating moderate to severe acne, with plans to submit the new drug application soon [1] - The Pre-NDA communication for ASC40 began in June 2025 and concluded in October 2025 [1] Group 2: Future Clinical Trials - Gilead has selected ASC35, a GLP-1R/GIPR dual agonist peptide, as a candidate for clinical development, expected to be submitted for an Investigational New Drug (IND) application to the FDA in the second quarter of 2026 [1] - ASC35 is being developed for use as a monotherapy and in combination therapy for treating cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [1]

Group 1 - The stock of Gilead Sciences-B (01672.HK) has increased by over 4% as of October 15, reaching a price of 9.49 HKD [1] - The trading volume for Gilead Sciences-B is reported at 23.58 million HKD [1]

Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a stock increase of over 4% following the announcement of its new drug application progress for ASC40, aimed at treating moderate to severe acne [1] Group 1: New Drug Application - Gilead Sciences has completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding ASC40 for treating moderate to severe acne [1] - The Pre-NDA communication took place from June 2025 to October 2025, with plans to submit the new drug application soon [1] Group 2: Clinical Development Candidates - Gilead Sciences has selected ASC35, a GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection [1] - The company plans to submit an Investigational New Drug (IND) application to the FDA for ASC35 in the second quarter of 2026, targeting obesity treatment [1] - ASC35 is being developed as both a monotherapy and combination therapy for treating cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [1]

Core Insights - The company has completed Pre-NDA communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne and plans to submit a New Drug Application soon [1][2] - Denifanstat (ASC40) has successfully met all primary, key secondary, and secondary efficacy endpoints in the Phase III study, showing significant improvement compared to placebo [2] - The safety profile of denifanstat (ASC40) is favorable, with all treatment-emergent adverse events being mild or moderate, and no severe adverse events reported [2] Company Developments - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) [1] - The results of the Phase III study were presented at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Insights - The company, Gilead Sciences-B (01672.HK), has recently completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne vulgaris [1][2] - Gilead plans to submit the New Drug Application shortly, following the completion of Phase II (NCT05104125) and Phase III studies (NCT06192264) for denifanstat [1] Group 1 - In the Phase III study, denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne vulgaris compared to placebo [2] - Denifanstat (ASC40) demonstrated good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2) [2] - There were no Grade 3 or 4 TEAEs related to denifanstat (ASC40), nor any serious adverse events (SAEs) associated with the treatment [2] Group 2 - Gilead reported the results of the Phase III study at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2]